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Clinical Trials/NCT06888427
NCT06888427RecruitingNot Applicable

Qualitative Analysis of Factors Affecting Perioperative Sleep Quality During Scheduled Surgery

Centre Hospitalier Universitaire de Nice1 site in 1 country1,000 target enrollmentStarted: April 23, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
1,000
Locations
1
Primary Endpoint
Determination of factors influencing sleep quality

Study Overview

Brief Summary

Many epidemiological studies report that insomnia is common after fifty years in the general population but also in the post-operative period of surgery. Preoperatively, sleep quality can be disturbed by fear of general anesthesia and surgery. Postoperatively, it seems to be altered by pain, the ambient environment and night care.

Literature shows that the occurrence of post-operative sleep disorders seems to lead to (increased) hypnotic consumption in patients who did not consume them in the pre-operative phase with known risks of dependence.

Nowadays , general anesthesia is widely practiced worldwide. However, despite continuous improvement in techniques, a large number of patients still experience poor quality postoperative sleep, even with short-term anesthesia.

It therefore appears that general anesthesia disrupts the circadian rhythm of patients, even if the mechanisms are still poorly understood.

Thus, sleep deprivation could be responsible of physiological alterations that are still unknown, such as delayed healing or impaired respiratory muscle performance, promoting postoperative complications.

The aim of this study is to identify the factors impacting the quality of sleep of patients undergoing scheduled surgery during the first postoperative night. And its implication on the occurrence of drowsiness described by the patient the day after their surgical intervention.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or female subject aged 18 years or older;
  • •Subject scheduled to undergo surgery under general anesthesia (orthopedic, thoracic, vascular or visceral surgery);
  • •Subject able to complete a self-administered questionnaire;
  • •Subject having given oral consent;

Exclusion Criteria

  • •Subject wishing to discontinue participation in the study before the end;
  • •Subject for whom the surgical procedure could not be performed after admission to the operating room (whatever the reason);
  • •Subject for whom the surgical procedure was performed urgently before the date initially scheduled (whatever the reason);
  • •Subject for whom a serious perioperative complication occurred during the surgical procedure

Arms & Interventions

Patients requiring scheduled surgery with post-operative hospitalization

Patients will pass questionnaires to assess their postoperative sleep quality

Intervention: Questionnaires (Other)

Outcomes

Primary Outcomes

Determination of factors influencing sleep quality

Time Frame: Day 1 post-operative

Sleep quality will be assessed using a self-questionnaire called Spiegel. It includes 3 items assessing sleep with a gradation from 0 to 5. An overall score is calculated, ranging from 0 (worst possible experience) to 15 (very good quality of sleep).

Secondary Outcomes

  • Determination of Sleepiness(Day 1 post-operative)
  • Determination of patient's perioperative satisfaction(Day 1 post-operative)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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